Vir Bio is seeking an Associate/Senior Associate to work within the CMC Analytical group, which includes Analytical Development, Quality Control, Raw Materials, and Process Analytics. This individual will support one or more of the following activities: laboratory startup operations, assay development activities, assay transfer and implementation, analytical services to support process development and stability studies, creation and maintenance of reagent inventories, and assay validation and maintenance programs. They will work cross-functionally with other groups within the department to develop, implement, and support the full complement of analytical methods and raw materials programs which support GMP manufacturing.

RESPONSIBILITIES:

• Participate in the startup of CMC Analytical laboratories, including establishing reagent supplies, ordering and commissioning instruments and equipment, and writing method SOPs
• Support and perform analytical method development
• Support and perform method lifecycle activities for analytical methods, including assay transfer, authoring and/or executing validation protocols and reports, executing assay maintenance programs, and qualifying new lots of critical reagents
• Maintain QC lab equipment and commission new equipment
• Author SOPs, protocols, and reports as required
• Assist in troubleshooting and evaluation of QC methods
• Support the creation and implementation of raw material programs and test methods
• Run analytical methods to support process and formulation development
• Conduct stability studies for drug products and critical raw materials
• Prepare and characterize critical assay reagents
• Maintain inventories of laboratory consumables, hazardous materials, and hazardous wastes
• Coordinate with vendors and suppliers to maintain laboratory equipment calibration and preventative maintenance schedules

QUALIFICATIONS:

• Experience in one or more of the following analytical areas:
  • virology methods, such as plaque assays or other viral titer methods
  • cell-based or other functional assays
  • flow cytometry
  • PCR or other molecular biology methods
  • ELISA, ELISpot, Western Blot, or other immunological assays
  • HPLC, mass spec, FTIR, UV-Vis, or other analytical chemistry methods
• Experience either in QC or developing analytical methods for transfer to QC, with experience in one or more areas of analytical method lifecycle (development, qualification, transfer, validation, maintenance) is preferred
• Technical writing skills and experience authoring SOPs, reports, or protocols
• Knowledge of/experience with laboratory automation, control charting software, or LIMS is a plus
• Ability to work in a high paced team environment, meet deadlines, and prioritize work from multiple projects
• Strong written and verbal communication skills, and ability to work on inter-disciplinary and cross-functional teams
• Proficiency in Microsoft Office applications is required

EDUCATION AND EXPERIENCE:

• BS/MS in biology, biochemistry, molecular biology, chemistry, or a related field
• Associate level: 4+ years of experience in a laboratory setting, including 2+ years in a QC or development lab, or equivalent combination of education and experience.
  • Senior Associate level: 8+ years of experience in a laboratory setting, including 4+ years in a QC or development lab, or equivalent combination of education and experience.

The Human Resources team manages the recruitment and employment process for Vir.  Unsolicited resumes sent to Vir from recruiters do not constitute any type of relationship between the recruiter and Vir and do not obligate Vir to pay fees should we hire from those resumes.  Recruiters are requested not to contact or present candidates directly to our hiring manager or employees.